Trial Information

Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic
radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are
difficult to treat and adversely impact patient quality of life. Various treatments directed
at the reduction of blood loss and improvement of other symptoms have been evaluated, with
the most encouraging results reported for two methods: endoscopic argon plasma coagulation
(APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of
sucralfate, a drug believed to enhance the mucosal defense and healing when administered
orally or rectally. Adequately powered randomized trials comparing various treatments are
lacking, and an optimal management strategy has yet to be determined. To address this issue,
we conducted a single-center, randomized, placebo-controlled, double-blind study comparing
the efficacy and safety of APC alone and APC in combination with sucralfate administered
orally.

Inclusion Criteria:

- radiotherapy due to pelvic tumors completed at least three months prior to enrollment

- history of clinically significant rectal bleeding prior to radiotherapy

- conditions predisposing the patient to rectal bleeding including inflammatory bowel
disease, tumors of the large bowel, intestinal vascular lesions (other than
radiation-induced telangiectasia), and diversion of the fecal stream

Start Date:

Completion Date:

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